Omlyclo

Medicinal product

(Invented) name

Omlyclo

Active substance (s)

Omalizumabas

Strength

75 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DX05, Omalizumab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2024-05-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename tirpalo užpildytame švirkšte (0,5 ml) yra	0.5 ml
Omalizumabas	75 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
113749	99866	1099866	užpildytas švirkštas	0,5 ml N1 (su adatos apsauga)		Receptinis	EU/1/24/1817/001	Netiekiama	-	-	No	-	-
118210	104318	1104318	užpildytas švirkštas	0,5 ml N3 (3×1) (su adatos apsauga)		Receptinis	EU/1/24/1817/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-16	Registruotas